Virtually all persons are occasionally stricken with acute upper respiratory infections (common colds), acute or chronic allergy flare-ups of the nose, and/or acute or chronic non-allergic rhinosinusitis. Significant discomfort and inconvenience are usually incurred by persons afflicted by such conditions. All of these disorders are characterized by intense inflammation of the nasal membranes (nasal turbinates). A number of symptoms which, at least in part, contribute to the discomfort and inconvenience associated with the common cold or other rhinosinusitis symptoms often include one or more of the following: nasal congestion, post-nasal drip, decreased sense of smell, ear fullness, headache, sore throat, malaise, muscle and joint aches, fatigue, cough, chest congestion, fever, chills and gastrointestinal maladies. Considerable research has been conducted over the years aimed at reducing the incidence and duration of symptoms associated with allergies and common colds, and at suppressing or eliminating their accompanying symptoms.
Current medications and treatments for rhinosinusitus provide only minimal symptom relief and some have undesirable side effects. Over-the-counter medications containing antihistamines sometimes cause drowsiness and impair cognitive judgment so that driving an automobile or operating other power driven machinery can be dangerous. Decongestants and adrenalin derivatives can elevate blood pressure, cause heart palpitations and stimulate brain activity causing insomnia or hyperalertness.
Over-the-counter decongestant sprays relieve some rhinosinusitis symptoms, but are associated with significant addictive, rebound phenomenon of the nasal membranes (Rhinitis Medicamentosa). As a result, over-the-counter decongestant sprays may actually lengthen the duration of common cold or rhinosinusitis symptoms.
Inhaled corticosteroid nasal sprays provide some relief for allergic rhinitis but do not reduce inflammation caused by acute viral infections, or inflammation associated with other forms of non-allergic rhinitis (atrophic rhinitis, vasomotor rhinitis, hormonally-induced vasomotor instability, etc.).
Vitamin compositions for treating disorders of the sino-nasal area do not have troubling side effects but heretofore have not shown a significant benefit in treating these disorders.
Several laboratory studies within the last two decades have shown that certain vitamins and other natural ingredients have anti-inflammatory properties. However, large scale clinical studies conducted in the 1980's using Vitamin C tablets showed that oral Vitamin C had no significant benefit in lessening the symptoms of the common cold.
Heretofore, aqueous solutions of ascorbic acid with a pH equal to or greater than 6.0 have been unstable and subject to quick oxidation by air. Solutions of ascorbic acid with a pH somewhat below 6.0 are undesirable because they tend to be irritating to some patients. Solutions with a pH equal to or greater than 6.0 have required precautions in preparation and use, by way of example, oxygen-free solvents, air tight packages, air tight misters, etc.
Applicants' studies have shown that to be therapeutically effective for treating rhinosinusitis, ascorbic acid must be applied to nasal membranes in higher concentration than heretofore used.
Applicants' studies have also shown that nasal spray solutions containing therapeutically effective amounts of ascorbic acid which have been prepared by methods other than Applicants' method have very short shelf lives because the ascorbic acid crystallizes out of solution.
Applicants' studies have also shown that nasal spray solutions containing ascorbic acid and caffeine in therapeutically effective amounts provide substantial benefits in treating acute and chronic rhinosinusitis.
Applicants' studies have also shown that nasal spray solutions containing ascorbic acid and caffeine at a pH of 6.5 do not require precautions in preparation and use, such as oxygen-free solvents, air-tight packages, air-tight misters, etc.
Deihl, J. A., U.S. Pat. No. 4,525,341 teaches a method for treating vitamin deficiency by spraying a solution containing small concentrations of vitamins and a breath freshening agent in an alcohol carrier into the nose or mouth.
Postley, J. E., U.S. Pat. No. 4,940,728 teaches a method for treating disorders of the sino-nasal area by spraying an alkaline solution (pH=7.8) containing small concentrations (13.3 mg/ml) of ascorbic acid and a salt or ester of ascorbic acid into the nasal mucous membrane.
Bates, H. L., U.S. Pat. No. 4,826,683 discloses a nasal spray for relieving nasal and sinus congestion consisting essentially of small concentrations of vitamin C, vegetable oil, and other vitamins and natural ingredients.